API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/apix-ig/ and changes regularly. See the Directory of published versions

: Type-II-Variation - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "Type-II-Variation",
  "type" : "transaction",
  "entry" : [
    {
      "fullUrl" : "urn:uuid:task-001",
      "resource" : {
        "resourceType" : "Task",
        "id" : "task-001",
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-001</b></p><a name=\"task-001\"> </a><a name=\"hctask-001\"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: proposal</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code submit-variation}\">Submit Type II Variation</span></p><p><b>description</b>: Type II variation for shelf life extension from 24 to 36 months</p><p><b>for</b>: <a href=\"MedicinalProductDefinition/mpd-001\">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29</p><p><b>requester</b>: <a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></p><p><b>owner</b>: <a href=\"Organization/ema\">Organization/ema</a></p></div>"
        },
        "status" : "requested",
        "intent" : "proposal",
        "code" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/task-code",
              "code" : "submit-variation",
              "display" : "Submit Type II Variation"
            }
          ]
        },
        "description" : "Type II variation for shelf life extension from 24 to 36 months",
        "for" : {
          "reference" : "MedicinalProductDefinition/mpd-001"
        },
        "authoredOn" : "2025-06-29",
        "requester" : {
          "reference" : "Organization/pharma-inc"
        },
        "owner" : {
          "reference" : "Organization/ema"
        }
      },
      "request" : {
        "method" : "POST",
        "url" : "Task"
      }
    },
    {
      "fullUrl" : "urn:uuid:doc-ref-001",
      "resource" : {
        "resourceType" : "DocumentReference",
        "id" : "doc-ref-001",
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_doc-ref-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference doc-ref-001</b></p><a name=\"doc-ref-001\"> </a><a name=\"hcdoc-ref-001\"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 51851-4}\">Administrative report</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>Type II Variation Application Form Collection Bundle</td></tr></table></blockquote><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>ePI Storage Update Document Bundle</td></tr></table></blockquote><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>PQI Stability Data Collection Bundle</td></tr></table></blockquote></div>"
        },
        "status" : "current",
        "type" : {
          "coding" : [
            {
              "system" : "http://loinc.org",
              "code" : "51851-4",
              "display" : "Administrative report"
            }
          ]
        },
        "content" : [
          {
            "attachment" : {
              "contentType" : "application/json",
              "data" : "base64 data placeholder",
              "size" : "1234",
              "hash" : "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
              "title" : "Type II Variation Application Form Collection Bundle"
            }
          },
          {
            "attachment" : {
              "contentType" : "application/json",
              "data" : "base64 data placeholder",
              "size" : "1234",
              "hash" : "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
              "title" : "ePI Storage Update Document Bundle"
            }
          },
          {
            "attachment" : {
              "contentType" : "application/json",
              "data" : "base64 data placeholder",
              "size" : "1234",
              "hash" : "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
              "title" : "PQI Stability Data Collection Bundle"
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "DocumentReference"
      }
    },
    {
      "fullUrl" : "urn:uuid:provenance-001",
      "resource" : {
        "resourceType" : "Provenance",
        "id" : "provenance-001",
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-001</b></p><a name=\"provenance-001\"> </a><a name=\"hcprovenance-001\"> </a><p>Provenance for <a href=\"Bundle-Type-II-Variation.html#DocumentReference_doc-ref-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 17:25:00-0400</td></tr></table><p><b>Agents</b></p><table class=\"grid\"><tr><td><b>Type</b></td><td><b>who</b></td></tr><tr><td><span title=\"Codes:{http://hl7.org/fhir/provenance-participant-type author}\">author</span></td><td><a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></td></tr></table></div>"
        },
        "target" : [
          {
            "reference" : "DocumentReference/doc-ref-001"
          }
        ],
        "recorded" : "2025-06-29T17:25:00-04:00",
        "agent" : [
          {
            "type" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/provenance-participant-type",
                  "code" : "author"
                }
              ]
            },
            "who" : {
              "reference" : "Organization/pharma-inc"
            }
          }
        ],
        "signature" : [
          {
            "type" : [
              {
                "system" : "urn:iso-astm:E1762-95:2013",
                "code" : "1.2.840.10065.1.12.1.1"
              }
            ],
            "when" : "2025-06-29T17:25:00-04:00",
            "who" : {
              "reference" : "Organization/pharma-inc"
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "Provenance"
      }
    },
    {
      "fullUrl" : "urn:uuid:application-form-001",
      "resource" : {
        "resourceType" : "Bundle",
        "id" : "application-form-001",
        "type" : "collection",
        "entry" : [
          {
            "fullUrl" : "urn:uuid:activity-definition-001",
            "resource" : {
              "resourceType" : "ActivityDefinition",
              "id" : "activity-definition-001",
              "status" : "draft",
              "description" : "Type II variation application for shelf life extension from 24 to 36 months"
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "Bundle"
      }
    },
    {
      "fullUrl" : "urn:uuid:epi-bundle-001",
      "resource" : {
        "resourceType" : "Bundle",
        "id" : "epi-bundle-001",
        "type" : "document",
        "entry" : [
          {
            "fullUrl" : "urn:uuid:epi-composition-001",
            "resource" : {
              "resourceType" : "Composition",
              "id" : "epi-composition-001",
              "status" : "preliminary",
              "type" : {
                "coding" : [
                  {
                    "system" : "http://loinc.org",
                    "code" : "34391-3",
                    "display" : "Product Labeling"
                  }
                ]
              },
              "title" : "Updated ePI for Monoclonal Antibody",
              "section" : [
                {
                  "title" : "Storage",
                  "text" : {
                    "status" : "generated",
                    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Store at 2-8°C for up to 36 months.</div>"
                  }
                }
              ]
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "Bundle"
      }
    },
    {
      "fullUrl" : "urn:uuid:pqi-bundle-001",
      "resource" : {
        "resourceType" : "Bundle",
        "id" : "pqi-bundle-001",
        "type" : "collection",
        "entry" : [
          {
            "fullUrl" : "urn:uuid:observation-001",
            "resource" : {
              "resourceType" : "Observation",
              "id" : "observation-001",
              "status" : "final",
              "code" : {
                "coding" : [
                  {
                    "system" : "http://loinc.org",
                    "code" : "76662-2",
                    "display" : "Stability study"
                  }
                ]
              },
              "valueString" : "Stability data supports shelf life extension to 36 months"
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "Bundle"
      }
    }
  ]
}